Leaving UL Solutions website
Within UL Solutions we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Approved/Notified Body and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brand, we have processes in place to identify and manage any potential conflicts of interest and maintain impartiality. UL Solutions is unable to provide consultancy services to EU MDD, MDR or IVDD Notified Body, UKCA MD Approved Body or MDSAP Customers.
  • News Story

REACH Regulation: Annex XVII Amendments Adopted by the EU Commission

On Dec. 16, 2020, the European Commission published several amendments to REACH on the manufacture, placing on the market and the use of dangerous substances, mixtures and articles.

Colorful test tubes

January 19, 2021

On Dec. 16, 2020, the European Commission published in the Official Journal of the European Union (OJEU) several amendments to the Registration, Evaluation, Authorisation and Restriction of Chemicals, referred to as REACH, under Annex XVII, which is the conditions of restriction — specifically on the manufacture, placing on the market and the use of dangerous substances, mixtures and articles.

We highlight the substantial additions below:

  • Category 1A and Category 1B carcinogenic substances added under entries 28, 29 and 30 to bring
Table - Entry 28 - CarcinogensTable - Entry 30 - reproductive toxicantsTable - Entry 30 - reproductive toxicants B

In addition, under Appendix 10, the table is replaced by the following harmonized standards regarding azo colorants:

European standards table

Source

X

Stay informed

Actionable insights on the topics you choose, delivered directly to your inbox.